Plain English Summary

Background and study aimsAppendicitis is a painful swelling of the appendix, a finger-like pouch connected to the large intestine. It is traditionally classified as uncomplicated or complicated, and is treated by removal of the appendix, known as an appendectomy or appendicectomy, which is the most commonly performed surgical procedure. Appendicectomy can be performed by one of two methods. Laparoscopic appendicectomy (LA) involves making several small cuts in your abdomen through which special surgical instruments are inserted. Open appendicectomy (OA) involves making a single larger cut in the abdomen. Currently the Department of Surgery at Chris Hani Baragwanath Hospital, Johannesburg, South Africa, practises both OA and LA in the treatment of perforated appendicitis (burst appendix). To date there have been no studies comparing outcomes between OA and LA in perforated appendicitis. The aim of this study is to compare the intra-operative duration, the rate of wound sepsis, the rate of relook, the length of hospital stay and the rate of re-admissions between the OA and LA groups. Additionally we aim to look at whether the duration of the symptoms has any effect on the outcome between the two procedures.

Who can participate? Patients presenting with acute abdomens suspected to be caused by perforated appendicitis at Chris Hani Baragwanath Hospital.

What does the study involve? Participants will be randomly allocated to undergo either OA or LA. A team of senior surgeons capable of doing both OA and LA will perform the surgery. Surgeons will perform standardized procedures in both subgroups as per current clinical guidelines.

What are the possible benefits and risks of participating? As this study will be comparing the outcomes of two different emergency surgical procedures, patients will be subjected to the risks which are associated with the surgical procedures. It must be noted that all patients recruited into the study need emergency surgery and thus inclusion in the study per se adds no additional risk factors to patients.

Where is the study run from? Chris Hani Baragwanath Hospital, Johannesburg, South Africa.

When is the study starting and how long is it expected to run for? The study began in December 2011 and ran for about 6 months.

Who is funding the study? There is no sponsor for the above trial. Should any minor costs be incurred they will be funded by the Department of Surgery, University of Witwatersrand, Johannesburg, South Africa.

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

Study hypothesis

In the treatment of perforated appendicitis, laparoscopic appendicetomy is associated with lower morbidity than open appendicetomy.

Ethics approval

Human Research Medical Ethics Committee, University of the Witwatersrand, Johannesburg, 27/11/2011, ref: M110730

Study design

Prospective single-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the conatct details below to request a patient information sheet

Condition

Appendicitis

Intervention

Open appendicetomy (OA) versus laparoscopic appendicetomy (LA)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Intra-operative duration2. The rate of wound sepsis3. The rate of re-look (the number of re-operations required as a result of the appendicitis or subsequent sequel of the appendicitis)4. The length of hospital stay 5. The rate of re-admissions

Secondary outcome measures

Whether the duration of the symptoms has any effect on the outcome between the two procedures